BEUDAMED
    FDA Adverse Event Injury Summary report: N

    OCTRODE

    MDR report key: 3231402 · Received July 12, 2013

    Report

    Report Number
    1627487-2013-00390
    Event Type
    Injury
    Date Received
    July 12, 2013
    Date of Event
    June 17, 2013
    Report Date
    June 17, 2013
    Manufacturer
    ST. JUDE MEDICAL - NEUROMODULATION
    Product Code
    LGW
    PMA / PMN Number
    P010032
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    SJM HAS LIMITED INFO RELATED TO THE PT'S MEDICAL HISTORY AND IS UNABLE TO FORM AN OPINION AS TO THE RELEVANCY OF THE PT'S HISTORY TO THE EVENT REPORTED. SJM DEFERS TO THE PT'S PHYSICIAN REGARDING MEDICAL HISTORY.

    Description of Event or Problem · 1

    THE PT (B)(6) WAS IMPLANTED WITH TWO PERCUTANEOUS LEADS FROM THE SAME LOT FOR OCCIPITAL NERVE STIMULATION. (OFF-LABEL) IT WAS REPORTED THE PT EXPERIENCED LEAD MIGRATION. SURGICAL INTERVENTION WAS UNDERTAKEN ON (B)(6) 2013 TO REPOSITION THE IMPACTED DEVICE. NO FURTHER ISSUES WERE REPORTED FOLLOWING THE PROCEDURE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    324650 OCTRODE SCS LEAD LGW ST. JUDE MEDICAL - NEUROMODULATION 3189 3925745

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK Other SCS EXTENSION: MODEL 3383 X 2| IMPLANT DATE:| IMPLANT DATE:| SCS IPG: MODEL 3788